The time has now come to take the next step, according to Warren Casey, Ph.D., director of the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM; see sidebar).

Creating a 3Rs roadmap

Casey and Brian Berridge, D.V.M., Ph.D., of GlaxoSmithKline, proposed the creation of a national roadmap to replace, reduce, or refine (3Rs) animal use and transform toxicity testing. “This is something much larger than ICCVAM, and much larger than the federal government,” said Casey. “It’s an incredibly complex proposition, but it’s also something that is absolutely necessary if we’re ever going to reach our goal.”

Both speakers cited the need for improved predictability of the effects of drugs and chemicals in humans. They also see opportunities to use computational and high-throughput assays to reduce animal use in some toxicological and drug safety and efficacy testing.

Those opportunities go hand in hand, said Berridge, at least in the drug development arena. “I have no doubt that if we can develop alternative ways of modeling that are more predictive and more efficient than what we do in animals, a decrease in animal dependence will follow,” he noted.

Upbeat updates

Casey also briefed the committee on many developments over the past year within NICEATM, including the creation of a new database that focuses on toxicants that produce subtle developmental effects. ICCVAM co-chair Anna Lowit, Ph.D., from the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs, described progress in implementing the priority needs identified in the 2013 ICCVAM reinvention.

The priorities include evaluating test methods for acute toxicity, biologics, skin sensitization, and endocrine disruptors. Organizational priorities call for agencies to take a more active role in committee activities, streamline the number of projects, and improve communications and outreach efforts. “We can pat ourselves on the back a little bit, because obviously there’s been an enormous amount of success,” Lowit reported.

The advisory committee also heard updates from four federal agencies that have been very active with ICCVAM-related work — the U.S. Department of Agriculture, EPA, the U.S. Food and Drug Administration, and NIEHS. At EPA, high-throughput and computational methods are contributing to an acceleration of the Endocrine Disruptor Screening Program. At NIEHS, a new small business cooperative agreements program has been announced to encourage validation and commercialization of approaches to reduce animal use in toxicity testing.

(Ernie Hood is a contract writer with the NIEHS Office of Communications and Public Liaison.)

Casey explained that the need for a national roadmap and strategy for the 3Rs is driven by public health, economics, and ethics, with each element contributing to reducing and eventually eliminating animal testing. “Development, validation, and adoption of predictive, human-based test methods requires multiple stakeholders all working together with specific intent,” he said.
(Photo courtesy of Steve McCaw)

Finding alternatives to animal testing

The term alternative methods refers to methods of research and testing that use fewer or no animals, or that reduce animal pain and distress. Congress established several groups to ensure the involvement of all stakeholders in development of such methods.

Lowit described EPA’s work with pesticide manufacturers to implement alternative tests or waive acute toxicity tests completely for pesticide reformulations. Such measures, she said, have resulted in significant reductions in the use of animals in testing. (Photo courtesy of Steve McCaw)

3/6

At her final meeting as a SACATM member, Tracie Bunton, D.V.M., Ph.D., right, from Eicarte LLC, addressed the challenge of measuring success. “Although we don’t have an edict to determine what the numbers are, I think it would be worthwhile to get a general idea of what the true usage of mice and rats and all of the animals are in the United States,” she said, as Nigel Walker, Ph.D., from NTP, listened. (Photo courtesy of Steve McCaw)

4/6

Amy Clippinger, Ph.D., left, and Jeffrey Brown, right, who represent People for the Ethical Treatment of Animals, provided comments during the meeting. (Photo courtesy of Steve McCaw)

5/6

David Dix, Ph.D., from EPA, described the Endocrine Disruptor Screening Program’s shift to using high-throughput assays and computational models to rapidly screen chemicals for potential bioactivity and exposure. This approach will increase in the rate of chemical screening from tens to thousands per year. (Photo courtesy of Steve McCaw)

6/6

SACATM and ICCVAM members and their NIEHS and NTP hosts had good reason to smile as they gathered for a photograph. “The number of ongoing and planned collaborations among agencies, industry, and our international partners is unprecedented in the 15 years since passage of the ICCVAM Authorization Act of 2000,” said Birnbaum, center front. (Photo courtesy of Steve McCaw)

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